The Epitope.RTM. Orasure.RTM. or Episcreen.TM. oral collection device is a commercially available product manufactured by the Epitope Corporation of Beaverton, Oregon. This is a collection device sealed by a cap at one end and having a frangible tip at the opposite end. Specimens are collected and preserved from the mouth of individuals for the analysis and diagnosis of disease, including HIV, hepatitis A, B, and C, and h. pylon, etc. Additionally, the test can detect the presence of metabolites such as cotinine or by products of drug use. Consequently, a potential biohazard is present.
Briefly stated, these devices are used in a process for collecting substances for testing, such as oral mucosal transudate (OMT) from a location in the mouth between the cheek and gum. The collection device comprises a porous absorbent member placed within a collection vial. The collection vial contains a sample preservative enclosed by a removable closure member, and a second closed end with frangible tip.
In use, the porous absorbent member collects oral fluid, which can constitute the biohazardous material. Utilizing a variety of steps, the absorbent member is inserted into the vial. Mixing of the absorbent member with preservative located in the vial occurs. The sealed vial, and saturated porous absorbent member is then shipped to a lab.
In the prior art, and at the lab, the sealed vial is inverted. The frangible tip is then broken off. A centrifuge tube is then placed over the outside of the vial. The sample tube and centrifuge tube are both inverted and centrifuged. During centrifugation, the preserved sample is separated from the porous member and the vial with the broken frangible tip. The pad and closure member are then removed and discarded, and the separated preserved sample is further analyzed.
This procedure has a possible biohazard. During the breaking of the frangible tip, exposure to the biohazard material is possible. First, direct skin contact is possible--where for example protective gloves rupture. Second, during breaking of the tip, an aerosol can form and be inhaled. In either case, an unacceptable biohazard condition results.